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Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01093911
First received: March 12, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657


Condition Intervention Phase
Immune System Diseases
Autoimmune Diseases
Lupus Erythematosus, Systemic
Skin and Connective Tissue Diseases
Connective Tissue Disease
Biological: CDP7657
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
  • Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP7657
CDP7657 in dose escalating cohorts
Biological: CDP7657
Ascending single doses of CDP7657
Placebo Comparator: Placebo Other: Placebo
Placebo: 0.9% sodium chloride aqueous solution

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Volunteers and subjects with SLE

Exclusion Criteria:

  • Severe neuropsychiatric or severe renal SLE
  • History of chronic, recurrent, or recent severe infection
  • Significant hematologic abnormalities
  • History of cancer, heart failure, renal disease, liver disease or other serious illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093911

Locations
Belgium
6
Leuven, Belgium
Bulgaria
9
Sofia, Bulgaria
Germany
1
Berlin, Germany
2
Erlangen, Germany
3
Frankfurt, Germany
4
Hannover, Germany
8
Kiel, Germany
7
Münster, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01093911     History of Changes
Other Study ID Numbers: SL0013, 2009-013617-10
Study First Received: March 12, 2010
Last Updated: January 3, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB Pharma:
Lupus
SLE

Additional relevant MeSH terms:
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Lupus Erythematosus, Systemic

ClinicalTrials.gov processed this record on November 20, 2014